Article | November 6, 2025

Achieve Speed, Stability, And Compliance In Cell Line Development

By Séverine Fagète, PhD, Site Head & Vice President, Mammalian Cell Line Development

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Cell line development (CLD) is the foundation for any successful biologic program. With biotech venture funding falling in Q2 of 2025, drug sponsors need to enlist both innovation and strong regulatory track records to secure the support of investors. One critical step to this goal is identifying innovative CLD technologies that demonstrate compliance with regulators alongside proven commercial success. To succeed in this, work with a CDMO that has designed breakthrough CLD technology with the ability to accommodate complex biologics and drive better timelines to market.

Working with an inexperienced CDMO or a CLD approach not tested in clinical or commercial manufacturing could result in scale-up or regulatory filing delays, resulting in repeated development cycles and delayed market entry. In a capital-constrained environment, these delays can be extremely detrimental to a sponsor’s success. To support sponsors as they navigate this highly competitive environment, KBI Biopharma designed its Selexis SUREtechnology Platform to conduct CLD that provides high-performing, stable cell lines. Download the full article to explore the possibilities of KBI’s cell lines to manufacture complex biologic molecules.

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